Deliverable 3.1. Assessment report on the implementation process

This deliverable report, pertaining to WP3, provides the outcomes of the mid-scale implementation pilot of the quality & utility labels being proposed (WP1) and implemented (WP2) within QUANTUM. The high-level objectives of QUANTUM WP3 (Mid-scale implementation of the label) are: Deploy the quality & utility label tool developed in WP2 in a larger group of health data holders participating in the project (“mid-scale test”). Feed the learnings from the mid-scale test into WP2 to further enhance the tool. Assess all aspects of the tool implementation process where data holders provide insights for transferability and sustainability. Translate the outcomes of the mid-scale test into guidance for the eventual Delegated and Implementing Acts derived from the application of the legislative proposal for the HealthData@EU. The activities of WP3 were divided into 4 tasks: 3.1 - Implementation plan (Nov. 2024 - Mar. 2025). Preparations for the mid-scale test through a series of interviews with representative data holders informing the ultimate implementation plan as outlined in the milestone report5. 3.2 - Mid-scale implementation pilot (Apr. 2025 – Dec. 2025). The execution of the mid-scale test: approach data holders to participate in the test, provide support to the test participants through a help desk, collect the test results, and interact with WP2 to incorporate the enhancements suggested by the testers in the new version of the tool. 3.3 - Implementation assessment (June 2025 – Dec 2025). Overall assessment of the test user experiences provides insights into aspects like feasibility, barriers, facilitators, institutional preparedness and governance, etc., informing future transferability and sustainability (Task 3.4). It also serves as feedback to improve the tool (WP2) and for further refinement of the quality, utility and maturity specification (WP1). 3.4 – Transfer and sustainability (Jan 2026 – Feb 2026). Translation of the outcomes of the mid-scale pilot to the real-life situation under HealthData@EU. Two workshops have been organised to define these conclusions and translate these into further recommendations to be incorporated in future Delegated and Implementing Acts under the EHDS. The present deliverable report (D3.1) provides the overall summary of the findings for the mid-scale implementation pilot of the QUANTUM quality and maturity labels. It constitutes the final summary of the work executed in three tasks, T3.1 to T3.3 as outlined below. WP3 has one more task, T3.4 (Transfer & Sustainability) focused on translating the findings of the mid-scale implementation test into recommendations for future implementation of the labels under the EHDS framework. The results of this task are summarised in a separate deliverable report, D3.2 (“Guidelines and specifications for the implementation of the QUANTUM labelling mechanism as foreseen in the legislative proposal for the development of HealthData@EU, article 56“).